Journal of Drug Delivery and Biotherapeutics
The Journal of Drug Delivery and Biotherapeutics (JDDB) is a distinguished peer-reviewed research journal known worldwide for its unwavering commitment to upholding the highest standards of scholarly publishing. Our journal has earned international acclaim for consistently delivering articles of exceptional quality and significance.
Advancements in Herbal Drug Lipidic Nanoparticles: Formulation, Applications, and Therapeutic Potential
Herbal drug lipidic nanoparticles (HDLNs) have emerged as an effective strategy for enhancing the bioavailability, stability, and therapeutic efficacy of herbal medicines. This review highlights the recent advancements in the formulation, applications, and therapeutic potential of HDLNs, focusing on various types of lipidic nanoparticles, such as liposomes, solid lipid nanoparticles, and nanoemulsions. The article discusses the techniques employed for the preparation of HDLNs, their advantages in drug delivery, and their role in targeted therapy for various diseases. Moreover, it covers the therapeutic benefits of HDLNs in enhancing the pharmacokinetics and overcoming challenges such as poor solubility and bioavailability of herbal compounds. The review also presents an outlook on the future directions of HDLNs, emphasizing their potential for personalized medicine and combination therapies
Copyright (c) 2025 Aarti Shastri https://creativecommons.org/licenses/by/4.0
Nanoemulsions in Drug Delivery: Advances, Applications, and Future Prospects in Therapeutic Nanomedicine
surfactants, offering unique advantages in drug delivery such as enhanced solubility, improved bioavailability, and targeted delivery of both hydrophilic and lipophilic drugs. Owing to their small droplet size (typically <200 nm), nanoemulsions exhibit excellent absorption, rapid onset of action, and reduced interpatient variability. This review discusses the recent advancements in the design, preparation techniques, and characterization of nanoemulsions for therapeutic applications. Emphasis is placed on the role of nanoemulsions in oral, parenteral, ocular, transdermal, and pulmonary delivery routes, with detailed analysis of their pharmacokinetic enhancements and clinical relevance. Additionally, the challenges related to formulation stability, toxicity, large-scale manufacturing, and regulatory considerations are highlighted. Future trends such as stimuli-responsive and targeted nanoemulsions for precision medicine are also explored. Overall, nanoemulsions represent a promising nanoplatform in modern drug delivery with wide-ranging pharmaceutical potential.
Copyright (c) 2025 Vishal Gurumukhi https://creativecommons.org/licenses/by/4.0
Lipid–Polymer Hybrid Nanoparticles for Depression Therapy: A Novel Strategy for Enhanced Brain Drug Delivery
the blood–brain barrier (BBB), poor drug bioavailability, and systemic side effects of conventional antidepressants. Nanotechnology-based drug delivery systems, particularly lipid–polymer hybrid nanoparticles (LPHNPs), have emerged as a promising approach to address these limitations. LPHNPs combine the advantages of both lipidic and polymeric nanocarriers—offering improved drug loading, stability, sustained release, and enhanced BBB penetration. This review highlights the current state of research on LPHNPs for antidepressant delivery, covering formulation strategies, physicochemical properties, targeting mechanisms, and in vitro/in vivo performance. The potential of LPHNPs to deliver selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), herbal bioactives, and neuroprotective agents directly to the brain is explored. Additionally, the challenges and regulatory perspectives for translating these hybrid systems into clinical therapies are discussed. Overall, LPHNPs represent a next-generation nanoplatform for targeted and effective treatment of depression.
Copyright (c) 2025 Anil Pawar https://creativecommons.org/licenses/by/4.0
Microneedle-Based Drug Delivery: Revolutionizing Transdermal Therapeutics for Painless and Precise Administration
Microneedle-based drug delivery systems have emerged as a transformative platform in transdermal therapeutics, offering a minimally invasive, painless, and highly targeted alternative to conventional drug administration routes. These systems consist of micron-scale needles that can penetrate the stratum corneum without reaching pain receptors, enabling efficient delivery of a wide range of therapeutic agents—including small molecules, proteins, peptides, and vaccines—directly into the dermis. Various types of microneedles, such as solid, coated, dissolvable, and hollow designs, have been engineered using biocompatible and biodegradable materials to suit specific clinical applications. Microneedles not only improve patient compliance but also bypass hepatic first-pass metabolism and allow self-administration. Recent advancements have shown significant promise in applications such as insulin delivery, vaccine immunization, and cancer therapy. Despite their potential, challenges remain in terms of large-scale manufacturing, regulatory approval, and long-term skin safety. This review highlights the current progress, design strategies, clinical applications, and future prospects of microneedle-based drug delivery systems in revolutionizing patient-centric transdermal therapy.
Copyright (c) 2025 Jeevan Rajguru https://creativecommons.org/licenses/by/4.0
Polymeric Nanoparticles for Drug Delivery: Design, Applications, and Future Perspectives
Polymeric nanoparticles have emerged as a promising platform in the field of drug delivery due to their ability to enhance the solubility, stability, and bioavailability of therapeutic agents. These nano-sized carriers, typically composed of biodegradable and biocompatible polymers such as PLGA, PEG, and chitosan, offer precise control over drug release kinetics and can be engineered for passive and active targeting. The versatility in design allows encapsulation of a wide range of drugs, including hydrophilic, hydrophobic, and biological molecules. Polymeric nanoparticles also exhibit potential in overcoming physiological barriers, reducing systemic toxicity, and improving therapeutic efficacy. Various surface modification strategies, including PEGylation and ligand attachment, further enhance their circulation time and targeting capability. Recent advancements have led to the development of stimuli-responsive and multifunctional polymeric systems, opening new avenues for personalized and precision medicine. Despite their advantages, challenges related to large-scale production, regulatory approval, and long-term safety must be addressed for successful clinical translation. This review highlights the design principles, fabrication techniques, therapeutic applications, and recent progress in polymeric nanoparticles, along with future perspectives in nanomedicine.
Copyright (c) 2025 Tejas Pachpute https://creativecommons.org/licenses/by/4.0
Advances in Targeted Drug Delivery Systems for Cancer Therapy: Nanotechnology to Clinical Translation
The treatment of cancer remains a significant challenge due to the limitations of conventional chemotherapeutics, including systemic toxicity, poor tumor specificity, and multidrug resistance. Targeted drug delivery systems have emerged as a transformative approach to improve the efficacy and safety of cancer therapy by selectively delivering therapeutic agents to tumor sites. Among these, nanotechnology-based carriers such as liposomes, polymeric nanoparticles, dendrimers, solid lipid nanoparticles, and micelles have demonstrated promising results in both preclinical and clinical settings. These nanocarriers enhance drug solubility, stability, and circulation time, and can be engineered for passive or active tumor targeting through surface modifications with ligands such as antibodies, peptides, and aptamers. Furthermore, stimuli-responsive systems that release drugs in response to tumor-specific triggers offer an added layer of precision. Several nanoformulations have been approved for clinical use, including Doxil and Abraxane, while others are progressing through clinical trials. Despite significant advancements, challenges such as large-scale manufacturing, regulatory hurdles, and long-term safety concerns continue to limit widespread clinical adoption. This review provides a comprehensive overview of the latest developments in targeted drug delivery systems for cancer, focusing on nanotechnology-enabled strategies and their journey toward clinical translation
Copyright (c) 2025 Dipali Zade https://creativecommons.org/licenses/by/4.0
Formulation and Pharmacological Evaluation of a Herbal Ointment Containing Blepharis repens for Topical Therapeutic Applications
Blepharis repens, commonly known as Hadsan in Marathi, is a medicinal herb from the Acanthaceae family, predominantly found in arid and rocky regions of India. Traditionally, it is utilized in managing bone fractures, dermatological conditions, urinary disorders, and allergic reactions. In the present study, an herbal ointment was formulated using the fusion method from various parts of Blepharis repens, focusing on its wound-healing potential. The formulation was systematically evaluated for its physicochemical properties, stability, and therapeutic relevance. Phytochemical screening revealed the presence of bioactive compounds including flavonoids, tannins, and saponins, known for their anti-inflammatory, antioxidant, and regenerative activities. Notably, the leaves exhibited significant wound-healing and anti-inflammatory effects, while the roots demonstrated bone-regenerative properties. These findings provide preliminary scientific support for the traditional topical use of Blepharis repens and underscore its potential in herbal dermatological formulations.
Copyright (c) 2025 Ms.Sheela Uttam Bankar , Ms.Nirmla Ashok musmade https://creativecommons.org/licenses/by/4.0
Alkaline Water in Skin Care: A Mini Review of Dermatological Benefits and Mechanisms
Alkaline water has recently gained attention in dermatology due to its potential benefits in skin care, including pH modulation, antioxidant activity, and hydration support. The skin’s natural acidic mantle plays a crucial role in barrier function and microbial balance, and alkaline water may help restore pH homeostasis disrupted by environmental stressors. Additionally, alkaline water exhibits antioxidant properties that can neutralize reactive oxygen species, thereby reducing oxidative damage and inflammation associated with skin aging and various dermatoses. While preliminary studies indicate positive effects on skin hydration, barrier repair, and inflammation control, clinical evidence remains limited and heterogeneous. Safety concerns related to excessive alkalinity highlight the need for balanced formulations to avoid barrier disruption. This mini review summarizes current knowledge on the dermatological mechanisms, benefits, and limitations of alkaline water, emphasizing the importance of future research to establish standardized protocols and confirm clinical efficacy. The integration of alkaline water in cosmeceuticals and therapeutic regimens holds promise for advancing skin care.
Copyright (c) 2025 Harshada Khandelwal https://creativecommons.org/licenses/by/4.0
Nitrosamine Impurities in Pharmaceutical Products: A Comprehensive Review of Sources, Analytical Detection Methods, Toxicological Risks, and Regulatory Guidelines
Nitrosamine impurities pose a significant health risk in pharmaceutical products due to their carcinogenic, mutagenic, and DNA-damaging properties. These organic compounds can form from various sources such as raw materials, intermediates, solvents, and packaging materials used in the manufacturing and storage of active pharmaceutical ingredients (APIs) and finished drug products. Contamination has been identified in drugs like ranitidine, nizatidine, metformin, and certain angiotensin II receptor blockers (ARBs). This review provides a comprehensive overview of the chemistry, sources, formation mechanisms, and environmental influences contributing to nitrosamine formation. It also discusses key analytical techniques for detection and quantification across APIs, excipients, and packaging components. Additionally, current global regulatory frameworks from the EMA, FDA, and USP are summarized, offering insights into permissible limits and compliance strategies. The article further explores challenges and preventive measures to control nitrosamine contamination, guiding pharmaceutical industries in quality assurance and risk management practices.
Copyright (c) 2025 Krishna Deore, Mr. Ismail Mouzam https://creativecommons.org/licenses/by/4.0
Design, Synthesis, Characterization, and Molecular Docking of Novel Teneligliptin Derivatives for Enhanced Antidiabetic Activity
The present study reports the synthesis and comprehensive characterization of three novel Dipeptidyl Peptidase-4 (DPP-4) inhibitor derivatives—D1 (Piperazine-substituted), D2 (Pyrrolidine-based), and D3 (Thiazole-substituted)—targeting improved antidiabetic activity. Structural confirmation was performed using Nuclear Magnetic Resonance (¹H-NMR and ¹³C-NMR) and Fourier Transform Infrared (FT-IR) spectroscopy, which verified the presence of key functional groups including amide, nitrile, and heterocyclic moieties. High-Performance Liquid Chromatography (HPLC) analysis demonstrated high purity and distinct retention profiles for each derivative, confirming successful synthesis without detectable impurities. Spectral data indicated consistent chemical shifts corresponding to the predicted molecular frameworks, supporting the integrity of these compounds. Notably, the thiazole-containing derivative exhibited characteristic C–S stretching vibrations confirming heterocyclic substitution. The variation in retention times suggested differing polarity and structural attributes, which may influence biological activity. These findings validate the molecular architecture of the synthesized compounds, laying a strong foundation for subsequent pharmacological evaluation. The study highlights the potential of these derivatives as promising candidates for diabetes treatment through DPP-4 inhibition, warranting further in-vitro and in-vivo investigations to explore their therapeutic efficacy and safety profiles.
Copyright (c) 2025 Akshada Khetre, Dr. Soni Madhusudan https://creativecommons.org/licenses/by/4.0
Advances in the Delivery of Biopharmaceuticals: Monoclonal Antibodies, Peptides, and Pulmonary mRNA and Gene Therapy
The rapid evolution of biopharmaceuticals, including monoclonal antibodies, peptides, and nucleic acid-based therapies, has revolutionized modern medicine. However, their clinical translation is often hindered by challenges in delivery, such as poor bioavailability, instability, and inadequate targeting. This review provides a comprehensive analysis of cutting-edge delivery strategies for biopharmaceuticals, with a focus on monoclonal antibodies and peptides, as well as emerging approaches for pulmonary mRNA and gene therapy. We explore innovative delivery systems, including nanoparticle-based carriers, lipid-based formulations, and advanced pulmonary delivery devices, which enhance therapeutic efficacy and minimize off-target effects. Furthermore, we discuss the potential of mRNA and gene therapies for treating respiratory diseases, emphasizing the role of the lungs as a prime target for non-invasive delivery. By addressing current limitations and future prospects, this review highlights the transformative potential of advanced delivery systems in unlocking the full therapeutic potential of biopharmaceuticals
Copyright (c) 2025 Manju Zade https://creativecommons.org/licenses/by/4.0
Innovative Approaches in Preformulation Studies for APIs: Shaping the Future of Drug Development
Preformulation studies play a pivotal role in the early stages of Active Pharmaceutical Ingredient (API) development, guiding the design and optimization of drug formulations. These studies focus on understanding the physicochemical properties, stability, solubility, and compatibility of APIs with excipients, thereby ensuring the development of a robust and effective pharmaceutical product. The primary goal is to evaluate the characteristics of an API that influence its formulation and delivery system, helping to identify potential challenges early in the process. This article explores the significance of preformulation studies, their methodologies, and the latest innovations in the field. It also emphasizes the integration of novel analytical techniques and predictive models, which enhance the accuracy and efficiency of API development. With increasing complexity in drug design, these studies are indispensable in minimizing formulation risks and optimizing therapeutic efficacy, ensuring the success of drugs in clinical trials and eventual commercialization.
Transforming Pharmaceutics and Pharmacology: The Pivotal Role of Artificial Intelligence in Shaping the Future of Drug Development
Artificial Intelligence (AI) is increasingly shaping the landscape of pharmaceutics and pharmacology by introducing innovative methodologies for drug discovery, development, and personalized medicine. With AI's capability to process and analyze large datasets, its application in predicting drug interactions, identifying novel drug candidates, and optimizing formulations is revolutionizing the pharmaceutical industry. AI-driven technologies, such as machine learning, deep learning, and neural networks, have the potential to significantly reduce the time and cost associated with drug development while enhancing the precision and efficacy of treatments. This review explores the various applications of AI in pharmaceutics and pharmacology, discussing its role in drug design, formulation development, pharmacokinetics, and personalized medicine. Furthermore, it examines the challenges and ethical considerations that arise as AI continues to integrate into these fields, highlighting its transformative potential and future directions
Copyright (c) 2025 Dr. Tejas Pachpute https://creativecommons.org/licenses/by/4.0
Pharmacokinetic and Dynamic Mechanisms in Drug Delivery Systems for Enhanced Therapeutic Efficacy
The success of drug delivery systems (DDS) relies heavily on understanding the pharmacokinetic and dynamic mechanisms that govern the movement and effect of therapeutic agents within the body. Pharmacokinetics focuses on the absorption, distribution, metabolism, and excretion (ADME) processes of drugs, while pharmacodynamics deals with the interaction between the drug and its target site to elicit a therapeutic response. The optimization of these mechanisms is crucial for improving drug efficacy, minimizing side effects, and enhancing patient outcomes. Recent advances in nanotechnology, liposomal formulations, and targeted delivery systems have significantly contributed to overcoming challenges related to bioavailability, stability, and controlled release. This review explores the intricate relationship between pharmacokinetic profiles and dynamic responses, highlighting how they influence the design and development of DDS. Moreover, we discuss the critical role of factors such as drug formulation, route of administration, and the pathophysiological conditions of the target site in modulating drug behavior. By understanding and manipulating these mechanisms, future DDS can be more tailored and effective in treating a wide range of diseases, including cancer, neurological disorders, and chronic conditions. The continuous evolution of pharmacokinetic and pharmacodynamic strategies promises a future of more precise and personalized drug delivery therapies.
Copyright (c) 2025 Alka Zade https://creativecommons.org/licenses/by/4.0
Recent Advances in Nanoparticle-Based Drug Delivery Systems: Challenges and Opportunities
Biotherapeutics have revolutionized modern medicine, offering targeted therapies for complex diseases. However, challenges such as poor bioavailability, rapid degradation, and limited targeting remain significant obstacles. Drug delivery systems (DDS) have emerged as crucial tools for improving the efficacy and stability of biotherapeutics. This review explores recent advancements in DDS, focusing on novel nanotechnology-based approaches that enhance drug delivery and targeting. Nanoparticles, liposomes, solid lipid nanoparticles (SLNs), and polymeric micelles are highlighted for their ability to encapsulate diverse therapeutic agents, including proteins, nucleic acids, and small molecules. These systems offer advantages such as enhanced permeability and retention (EPR) effects, targeted delivery, and controlled release, which can significantly improve treatment outcomes. However, challenges regarding toxicity, scalability, and regulatory hurdles must be addressed before these technologies can be widely implemented in clinical practice. The future of DDS is closely tied to overcoming these challenges through innovations in manufacturing processes and the development of more biocompatible, biodegradable systems. This review provides a comprehensive overview of the state-of-the-art in DDS, with a particular emphasis on their application in biotherapeutic drug delivery, offering insights into potential future developments.
Enhanced Permeability and Retention (EPR)
Copyright (c) 2025 Dr. Aarti Shastri, Anil Pawar https://creativecommons.org/licenses/by/4.0
Phytochemical Insights into Anti-Aging Properties of Herbal Plants: A Pharmacognostic Review
Anti-aging therapies have gained significant attention due to the increasing global demand for solutions to mitigate the visible effects of aging and promote healthy longevity. Herbal plants have long been utilized for their potential medicinal properties, including anti-aging effects, owing to their rich phytochemical composition. This review aims to explore the pharmacognostic properties of various anti-aging herbal plants by focusing on their bioactive compounds and mechanisms of action. Through a comprehensive analysis of recent literature, we identify key phytochemicals such as polyphenols, flavonoids, alkaloids, and terpenoids, which have been linked to cellular protection, collagen synthesis, and free radical scavenging. Additionally, we discuss the molecular pathways influenced by these compounds, including the inhibition of oxidative stress, modulation of inflammation, and regulation of age-related proteins like sirtuins. The potential of these herbal plants as therapeutic agents for delaying or reversing the aging process is examined, emphasizing their safety, efficacy, and the need for further clinical validation. This review highlights the promising role of pharmacognosy in identifying and developing natural anti-aging therapies and provides insights into future research directions for harnessing the full potential of these botanical resources.
Copyright (c) 2024 Mr. Sagar Tambe https://creativecommons.org/licenses/by/4.0
Nanomedicine: Current Trends, Applications, and Future Prospects
Nanomedicine, the application of nanotechnology in medicine, is an emerging field that holds great promise for improving disease diagnosis, treatment, and prevention. By leveraging the unique properties of nanoparticles, such as their small size, high surface area, and ability to deliver drugs more efficiently, nanomedicine is poised to revolutionize various therapeutic areas, including oncology, infectious diseases, and tissue engineering. This review article explores the current trends in nanomedicine, highlighting the latest advances, challenges, and future prospects. It provides a comprehensive overview of the types of nanoparticles used in medical applications, their drug delivery mechanisms, clinical applications, and safety considerations. Emphasis is placed on the importance of translating nanomedicine from laboratory settings to clinical practice, with a focus on overcoming the barriers related to toxicity, biocompatibility, and regulatory approval.
Copyright (c) 2024 Ashwini Jadhav https://creativecommons.org/licenses/by/4.0
Liver X Receptor (LXR) Activation as a Potential Therapeutic Strategy for the Management of Hypertension: A Comprehensive Review
Hypertension remains one of the leading causes of mortality globally, with complex mechanisms involving hormonal regulation and vascular reactivity. Recent studies have identified the Liver X receptor (LXR) as a potential key modulator in the regulation of blood pressure and vascular function. LXRs play a critical role in the modulation of the renin-angiotensin-aldosterone system (RAAS), which is central to blood pressure homeostasis. This review explores the relationship between LXRs and hypertension, emphasizing the role of LXR agonists in modulating renin gene transcription and angiotensin II (Ang II)-mediated vascular responses. LXR activation has been shown to downregulate angiotensin II receptor expression (AT1 and AT2), thereby reducing vascular responsiveness to Ang II and lowering blood pressure. Additionally, LXR agonists such as T0901317 and GW3965 have been demonstrated to decrease NF-κB and TNF-α expression in hypertensive models, contributing to reduced inflammation and improved endothelial function. Moreover, LXR agonists enhance nitrite production and improve nitric oxide (NO) bioavailability, which are crucial for vascular health. These findings highlight the potential of LXRs as therapeutic targets for hypertension management. Targeting LXR pathways could provide a novel approach to controlling blood pressure through modulation of the RAAS and inflammatory pathways, offering new avenues for therapeutic intervention in hypertensive patients.
Copyright (c) 2024 Dipti Patil https://creativecommons.org/licenses/by/4.0
Evaluating the Efficacy of Herbal Medicines in the Management of Constipation: A Comprehensive Review
Constipation is a common gastrointestinal disorder that affects a significant portion of the global population. While conventional treatments such as laxatives offer temporary relief, their potential side effects and long-term dependency have prompted increased interest in alternative therapies. Among these, herbal medicines have gained recognition for their perceived safety and effectiveness. This comprehensive review evaluates the efficacy of various herbal remedies commonly used in the management of constipation, including senna, psyllium, aloe vera, cascara sagrada, fennel, rhubarb, slippery elm, and ginger. The review discusses the mechanisms of action of these herbs, their clinical efficacy, and potential side effects. Fiber-based herbs like psyllium are shown to be effective for long-term management, while stimulant herbs such as senna and cascara provide short-term relief. The review highlights the importance of personalized approaches to treatment and emphasizes the need for further research to validate the long-term safety and efficacy of herbal remedies. Despite the promising potential of herbal medicines, more rigorous clinical trials and a deeper understanding of their mechanisms are essential to fully integrate these natural alternatives into modern healthcare practices
Copyright (c) 2024 Sunil Kanadje https://creativecommons.org/licenses/by/4.0
Hepatotoxicity Associated with Anti-Tuberculosis Medications: Analyzing Mechanisms, Risk Factors, and Strategies for Prevention and Management
Hepatotoxicity associated with anti-tuberculosis (TB) medications represents a significant challenge in the management of TB, often complicating treatment regimens and increasing the risk of adverse outcomes. This review aims to analyze the mechanisms underlying hepatotoxicity induced by commonly used anti-TB drugs, such as isoniazid, rifampicin, pyrazinamide, and ethambutol. The liver toxicity mechanisms involve drug-induced immune responses, mitochondrial dysfunction, oxidative stress, and the disruption of hepatocyte metabolism. Furthermore, the review explores various risk factors contributing to hepatotoxicity, including pre-existing liver conditions, genetic polymorphisms, alcohol consumption, co-infections (e.g., HIV), and age-related susceptibility. Additionally, strategies for the prevention, early detection, and management of hepatotoxicity are discussed, emphasizing dose adjustments, liver function monitoring, the use of hepatoprotective agents, and alternative drug regimens. Effective management approaches are essential to ensure treatment adherence and prevent the progression of liver damage. The review concludes by underscoring the importance of personalized medicine and the need for further research to better understand the pathophysiology of anti-TB drug-induced hepatotoxicity and to develop safer therapeutic strategies for TB patients.
Copyright (c) 2024 Dipali D. Zade https://creativecommons.org/licenses/by/4.0
Development And Validation of a Stability-Indicating RP-HPLC Assay Method for Atazanavir Sulfate in Bulk Drug and Capsule Dosage Form, and Its Application In Dissolution Studies
This research aimed to develop and validate a stability-indicating RP-HPLC method for the quantitative estimation of Atazanavir sulfate in both bulk drug and capsule dosage forms. The method's specificity was established through stress tests, demonstrating its ability to accurately quantify Atazanavir sulfate in the presence of potential degradation products. Validation parameters including linearity, accuracy, precision, and robustness were assessed in accordance with ICH guidelines, confirming the method's reliability and suitability for routine pharmaceutical analysis. Additionally, the developed RP-HPLC method was applied to conduct a dissolution study of Atazanavir sulfate capsules, providing valuable insights into its dissolution behavior under specified conditions. The dissolution method was validated for linearity, precision, and accuracy, further supporting its applicability for dissolution testing purposes. Results from the stability-indicating RP-HPLC method revealed the drug's stability under various stress conditions, with significant degradation observed only in base degradation. The dissolution study highlighted the drug's consistent release profile over the specified time intervals. Overall, the developed methods offer reliable and specific means for the quantitative analysis and dissolution testing of Atazanavir sulfate, contributing to pharmaceutical quality control and stability assessment. These methods are poised to facilitate routine analytical procedures in pharmaceutical laboratories, ensuring the quality, safety, and efficacy of Atazanavir sulfate-based products.
Copyright (c) 2024 © 2024 Sennos Biotech All rights reserved.
Nanotechnology-Based Approaches for Parkinson’s Disease: Progress in Drug Delivery and Regenerative Medicine
Nanotechnology is emerging as a promising frontier in the development of next-generation drug delivery systems, offering innovative solutions to address the challenges associated with Parkinson’s Disease (PD). PD, a neurodegenerative disorder characterized by the loss of dopaminergic neurons, poses significant therapeutic obstacles, including poor drug solubility and stability, low permeability across the blood-brain barrier (BBB), and a lack of treatment specificity. Nanotechnology-based approaches provide opportunities to overcome these limitations by improving drug delivery, enhancing neuroprotection, and supporting neuronal regeneration. This review focuses on several nanotechnology-driven strategies, including lipid- and polymeric-based nanoparticles that improve drug solubility, stability, and targeted delivery across the BBB. It also examines the application of CRISPR-Cas9 delivery systems for precise gene editing, offering disease-modifying potential, and explores the integration of stem cell-based regenerative therapies for restoring dopaminergic neurons and repairing damaged neural networks. Beyond these approaches, the potential for nanotechnology to enable personalized treatments and novel therapeutic interventions is discussed. While nanotechnology holds significant promise in advancing PD management, critical challenges remain, including concerns about safety, reproducibility, scalability, and clinical adaptation.
Copyright (c) 2024 Journal of Drug Delivery and Biotherapeutics
Development and Validation of a Stability-Indicating RP-HPLC Assay Method For The Estimation Of Rizatriptan Benzoate In Tablet Dosage Form
This research endeavors to develop and validate a robust method for the assay of Rizatriptan Benzoate tablets utilizing RP-HPLC. Conducted at the Laboratory of ARL in Glenmark Research Centre, Navimumbai, the study encompasses comprehensive investigations into method development and validation protocols. The research begins with an introduction to method development and validation, elucidating various chromatography techniques, HPLC instrumentation, and analytical methodologies. A thorough literature survey reveals existing methods for the drug, laying the groundwork for subsequent experimentation. Subsequent chapters delve into the drug profile, including its physical characteristics, structure, solubility, pharmacological action, and ADME properties. The aim and objectives of the study are outlined, followed by a detailed exploration of the experimental procedures conducted during method development. Various approaches to HPLC method development are explored, with a focus on optimizing chromatographic conditions. The validation protocol is meticulously outlined, covering specificity, linearity, precision, accuracy, ruggedness, and robustness parameters. The validated method demonstrates exceptional performance characteristics, paving the way for routine assay applications in the pharmaceutical industry. Results of the assay method development, including optimized chromatographic conditions and standard concentrations, are presented.In conclusion, the validated method emerges as a reliable tool for the routine assay of Rizatriptan Benzoate tablets, offering specificity, precision, linearity, robustness, and sensitivity. This research contributes to the advancement of pharmaceutical quality control processes, ensuring the safety and efficacy of Rizatriptan Benzoate formulations.
Copyright (c) 2024 Journal of Drug Delivery and Biotherapeutics (JDDB)
UV Spectrophotometric Evaluation of Drug Solubility Profiles in Varied Pharmaceutical Formulations
This study aimed to develop a method for comparing the solubility profiles of three distinct brands of Diclofenac Sodium formulations using UV spectrophotometry. The analysis was conducted under optimal dissolution conditions, employing 900 mL of pH 7.4 phosphate buffer as the dissolution medium, with a paddle apparatus (Type II) set to 100 revolutions per minute. A wavelength of 282.2 nm was used for the UV spectrophotometric measurement of drug release. The proposed method demonstrated a drug release percentage close to 100%, aligning well with the labeled claims of the marketed tablet formulations. This approach provides a simple, precise, and reliable technique for comparative analysis of solubility profiles across various formulations, supporting pharmaceutical quality control and formulation optimization.
Forced Degradation Studies: Analytical Methodologies, Applications, and Regulatory Insights – A Systematic Review
Forced degradation studies are an essential component of pharmaceutical development, designed to intentionally degrade drug substances and products under conditions more rigorous than standard accelerated conditions. These studies play a pivotal role in validating the specificity of stability-indicating analytical methods. By exposing drug substances to various stress conditions, forced degradation reveals degradation pathways and identifies degradation products, providing critical insights into the molecular stability and chemical behavior of active pharmaceutical ingredients. These insights are instrumental in guiding formulation design, packaging development, and shelf-life determination. However, despite its significance, regulatory guidelines on forced degradation often lack comprehensive instructions, leaving the execution and interpretation of these studies to the discretion of researchers. This review aims to address this gap by providing a systematic examination of forced degradation methodologies, elucidating degradation mechanisms, and summarizing analytical techniques integral to stability-indicating method development. Additionally, it highlights current trends and challenges in forced degradation research, contributing to the advancement of robust and reliable analytical approaches in pharmaceutical science
Navigating Drug Regulatory Affairs: An Analytical Review of Compliance in the Pharmaceutical Industry
Drug Regulatory Affairs (DRA) plays a critical role within pharmaceutical companies, ensuring the health and safety of consumers while maintaining the integrity of pharmaceutical products. This discipline provides strategic and informed oversight to guarantee compliance with legal and regulatory requirements, expediting the development and approval of safe and effective drugs. Regulatory affairs professionals work across diverse sectors, including government agencies, the pharmaceutical industry, academia, and clinical research organizations. Their responsibilities encompass devising and implementing regulatory strategies, ensuring that drug development processes align with global standards while enhancing competitiveness in the market. The scope of DRA extends across the entire lifecycle of a pharmaceutical product, from preclinical research and development to manufacturing, marketing, and post-marketing surveillance. Additionally, the DRA department serves as the primary interface between the company and regulatory authorities, ensuring seamless communication and compliance at every stage of drug development and commercialization. Through its multifaceted role, DRA not only safeguards public health but also contributes to the efficient and successful introduction of pharmaceutical innovations.
Recent Innovations in High-Performance Liquid Chromatography (HPLC): Method Development and Validation Strategies
High-Performance Liquid Chromatography (HPLC) has established itself as a cornerstone in analytical chemistry, playing a pivotal role in the separation, identification, and quantification of compounds in complex mixtures. Over the years, significant advancements in HPLC method development and validation have enhanced its precision, accuracy, and application scope across pharmaceutical, environmental, and food industries. This review delves into recent innovations in HPLC, emphasizing robust method development strategies that ensure reproducibility and reliability. Key aspects, such as the selection of stationary and mobile phases, optimization of chromatographic parameters, and advanced gradient programming, are explored in detail. Additionally, this review highlights contemporary validation techniques, including system suitability testing, linearity assessment, and specificity evaluation, which are critical to meeting regulatory compliance. Recent technological advancements, such as the integration of chemometric tools, high-resolution detectors, and environmentally friendly solvents, are also discussed, showcasing their impact on method efficiency and sustainability. The article aims to provide a comprehensive understanding of HPLC method development and validation for researchers and industry professionals, bridging the gap between traditional practices and modern innovations. By summarizing challenges and proposing future directions, this review underscores the evolving nature of HPLC as a versatile analytical tool in various scientific domains.
Silica Nanoparticles: Navigating the Toxicological Terrain – An In-Depth Exploration of Multifaceted Health Impacts
Silica nanoparticles have emerged as versatile materials with widespread applications, particularly in industries ranging from medicine to electronics. However, their increasing ubiquity raises concerns about potential adverse health effects. This review delves into the intricate landscape of the toxicological effects associated with silica nanoparticles, aiming to provide a comprehensive understanding of their multifaceted impact on human health. Drawing from a vast body of research, we explore diverse aspects, including respiratory, cardiovascular, and dermal effects, as well as potential implications for reproductive and immune systems. The intricate interactions between silica nanoparticles and biological systems are scrutinized, shedding light on cellular mechanisms and pathways involved in toxicity. Additionally, the influence of physicochemical properties, such as size, surface charge, and shape, on the toxicity profile is thoroughly examined. Insightful discussions on exposure routes, dosimetry, and risk assessment contribute to a holistic perspective on the potential hazards associated with silica nanoparticles. As we navigate through this toxicological terrain, it becomes evident that a nuanced understanding of the complex interactions between silica nanoparticles and the human body is imperative for informed decision-making in both scientific and regulatory realms. This review not only synthesizes existing knowledge but also identifies critical research gaps, paving the way for future investigations aimed at elucidating the intricacies of silica nanoparticle toxicity.
Development and Validation of Stability Indicating Methods by Chromatography: A Review
High Performance Liquid Chromatography has become a powerful technique in analytical chemistry which evaluates drug product stability. This is most accurate method for quantitative and qualitative determination in the analysis of drug product. Forced degradation has a most crucial role in the development of stability indicating HPLC methods to separate various drug related impurities found during production or synthesis of drug product. This article will focus on strategies and areas of concern relevant to development of stability indicating methods by HPLC. Forced degradation studies provide us with degradation pathways of drug substances and products.
Microemulsion-Based Drug Delivery Systems: Harnessing Nanostructures for Enhanced Therapeutic Efficacy
Microemulsions represent a unique class of dispersions characterized by their transparent or translucent appearance. These systems have garnered significant attention as promising drug delivery vehicles due to several advantageous properties. Notably, microemulsions offer prolonged shelf life, enhanced drug solubilization, and ease of preparation and administration. Comprising thermodynamically stable and optically isotropic liquid solutions of oil, water, and amphiphile, they maintain constant droplet sizes typically ranging from 10 to 100 nm, along with minimal oil/water interfacial tension. As such, microemulsions serve as versatile carriers for controlled or sustained drug release across various administration routes including ocular, percutaneous, topical, transdermal, and parenteral applications. Importantly, they effectively enhance drug therapeutic efficacy while minimizing toxic side effects by reducing the volume of the drug delivery vehicle. Moreover, microemulsions facilitate the absorption of lipophilic drugs by aiding in their solubilization within cell membranes, further underscoring their potential as valuable tools in pharmaceutical formulations.